Disposable syringes are in widespread use for a number of different types of applications. For example, syringes are used not only to withdraw a fluid (e.g., blood) from a patient but also to administer a medication to a patient. In the latter, a cap or the like is removed from the syringe and a unit dose of the medication is carefully measured and then injected or otherwise disposed within the syringe.
As technology advances, more and more sophisticated, automated systems are being developed for preparing and delivering medications by integrating a number of different stations, with one or more specific tasks being performed at each station. For example, one type of exemplary automated system operates as a syringe filling apparatus that receives user inputted information, such as the type of medication, the volume of the medication and any mixing instructions, etc. The system then uses this inputted information to disperse the correct medication into the syringe up to the inputted volume.
In some instances, the medication that is to be delivered to the patient includes more than one pharmaceutical substance. For example, the medication can be a mixture of several components, such as several pharmaceutical substances.
By automating the medication preparation process, increased production and efficiency are achieved, as well as an increase in patient safety since manual manipulation, a principal cause of microbial contamination, is avoided. This results in reduced production costs and also permits the system to operate over any time period of a given day with only limited operator intervention for manual inspection to ensure proper operation is being achieved. Such a system finds particular utility in settings, such as large hospitals, including a large number of doses of medications that must be prepared daily. Traditionally, these doses have been prepared manually in what is an exacting but tedious responsibility for a highly skilled staff. In order to be valuable, automated systems must maintain the exacting standards set by medical regulatory organizations, while at the same time simplifying the overall process and reducing the time necessary for preparing the medications.
Because syringes are used often as the carrier means for transporting and delivering the medication to the patient, it is advantageous for these automated systems to be tailored to accept syringes. However, the previous methods of dispersing the medication from the vial and into the syringe were very time consuming and labor intensive. More specifically, medications and the like are typically stored in a vial that is sealed with a safety cap or the like. In conventional medication preparation, a trained person retrieves the correct vial from a storage cabinet or the like, confirms the contents and then removes the safety cap manually. This is typically done by simply popping the safety cap off with one's hands. Once the safety cap is removed, the trained person inspects the integrity of the membrane and cleans the membrane. An instrument, e.g., a needle, is then used to pierce the membrane and withdraw the medication contained in the vial. The withdrawn medication is then placed into a syringe to permit subsequent administration of the medication from the syringe.
A conventional syringe includes a barrel having an elongated body that defines a chamber that receives and holds a medication that is disposed at a later time. An outer surface of the barrel tip or luer can include features to permit fastening with a cap. As previously mentioned, the term “medication” refers to a medicinal preparation for administration to a patient and most often, the medication is contained within the chamber in a liquid state even though the medication initially may have been in a solid state, which was processed into a liquid state. The syringe further includes a plunger that is removably and adjustably disposed within the barrel.
Typically, a drug is provided off the shelf in solid form within an injectable drug vial that is initially stored in a drug cabinet or the like. To prepare an injectable unit dose of medication, a prescribed amount of diluent (water or some other liquid) is added to the vial to cause the solid drug to liquefy. Mixing and agitation of the vial contents is usually required. This can be a time consuming and labor intensive operation since first it must be determined how much diluent to add to achieve the desired concentration of medication and then this precise amount needs to be added and then the vial contents need to be mixed for a predetermined time period to ensure that all of the solid goes into solution. Thus, there is room for human error in that the incorrect amount of diluent may be added, thereby producing medication that has a concentration that is higher or lower than it should be. This can potentially place the patient at risk and furthermore, the reconstitution process can be very labor intensive since it can entail preparing a considerable number of medication syringes that all can have different medication formulations. This also can lead to confusion and possibly human error. There is also an opportunity for microbial contamination when the operation is performed by hand.
If the medication needs to be reconstituted, the medication initially comes in a solid form and is contained in an injectable drug vial and then the proper amount of diluent is added and the vial is agitated to ensure that all of the solid goes into solution, thereby providing a medication having the desired concentration. The drug vial is typically stored in a drug cabinet or the like and is then delivered to other stations where it is processed to receive the diluent.
As is known, the drug vial typically includes a some type of label that is affixed to the outer surface of the drug vial and serves to identify the contents of the drug vial. For example, a label is typically affixed to the drug vial using conventional means, such as the use of an adhesive, and contains certain indicia that serves to identify the contents of the container. More specifically, the label typically includes printed identifying indicia including the name of the medication that is contained therein, the dosage amount of the medication and manufacturer information.
Information must be presented in a standardized, easy-to-follow format, usually on the package's outside container or wrapper. Under the title “Drug Facts,” the product's active ingredients will be listed first, along with the purpose for each, followed by uses, warnings, directions, and inactive ingredients. Listing inactive ingredients is a new requirement that should help consumers avoid products that may cause an allergic reaction. Also, FDA recommends, but doesn't require, that manufacturers include a phone number on the label for consumers to call for more information.
There is an ongoing need and desire to provide an easy to read label and especially the inclusion of a bar code on the label that contains certain information that serves to identify and provide information about the contents of the container. The intent is to help reduce the number of medication errors in hospitals and health care settings by permitting and encourage and in some cases, mandating, that health care professionals use bar code scanning equipment to verify that the right drug, in the right dose, and right route of administration, is being given to the right patient at the right time. Medication errors are a serious public health problem and the use of technologically advances systems is expected to reduce medication errors. Although most medication errors do not result in harm to patients, medication errors can result and have resulted in serious injury to the patient. Medication errors also represent a significant economic cost to the United States.
While the use of bar codes is gaining momentum and the applicable government regulatory authorities have and are presently involved with rulemaking on this topic; there are still a number of system deficiencies that need to be addressed and remedied. For example, studies have indicated that only about 20–30 percent of all containers include a scanable safety feature, such as a bar code label. Moreover, while the bar code contains some information that identifies the drug, it does not include additional information that would assist in increasing the safety feature aspects of the bar code. For example, typically and as recommended in the applicable Federal Rules, the bar code includes, at a minimum, the drug's NDC number. The NDC number identifies each drug product that is listed with the applicable government agencies and its principle value is verifying that the correct drug in the correct dosage is being administered. Each drug product listed under Section 510 of the Federal Food, Drug, and Cosmetic Act is assigned a unique 10-digit, 3-segment number. This number, known as the National Drug Code (NDC), identifies the labeler/vendor, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. A labeler is any firm that manufactures, repacks or distributes a drug product. The second segment, the product code, identifies a specific strength, dosage form, and formulation for a particular firm. The third segment, the package code identifies package sizes. Both the product and package codes are assigned by the firm. The NDC will be in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1.
While the presentation of the NDC on a bar code label for use with on a drug container is helpful in reducing medication errors, there are a number of deficiencies with this system. For example, the bar code only contains information about the drug name and the dosage strength; however, the bar code does not contain information that relates to expiration dates for the drug and it does not contain information that relates to a lot number of the drug. The expiration date is an important piece of information in the drug dispensing operation since it permits the operator to determine whether the drug is outdated for administration. A drug that is past its expiration date is potentially ineffective in treating the patient and therefore can be potentially hazardous for the patient. In addition, lot information is the principle means by which drug recalls are announced and regulated. A drug recall is typically instituted for any number of reasons; however, most relate to the integrity of the drug and therefore, a recalled drug that is in distribution and use is likewise potentially hazardous to the patient.
What is needed in the art and has heretofore not been available is a system and method for automating the medication preparation process and more specifically, a safety and cost reducing feature that is capable of reading the entire surface of a label that is disposed on the drug vial for the purpose of reading drug identifying information and then instructing the system whether the read drug vial should be advanced to a next station or whether the drug vial should be discarded or otherwise not advanced and removed from further processing.